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Friday, 27 April 2018

One more milestone for Zydus: Receives US FDA approval for methylprednisolone and cinacalcet HCl tablets

Zydus Cadila has received the final approval from the US FDA to market methylprednisolone tablets USP in the strengths of 4 mg, 8 mg, 16 mg and 32 mg. These tablets are used to treat conditions such as arthritis, blood disorders, severe allergic reactions, certain cancers, eye conditions,
skin/kidney/intestinal/lung diseases and immune system disorders. It will be manufactured at the company’s formulations manufacturing facility at Moraiya, Ahmedabad.

The group also received the final approval to market cinacalcet hydrochloride tablets in the strengths of 30 mg (Eq. base), 60 mg (Eq. base) and 90 mg (Eq. base). It is indicated for the treatment of high blood calcium in patients with cancer of parathyroid glands and for the treatment of high blood parathyroid hormone levels seen in patients with chronic kidney disease on dialysis. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad.

The group now has more than 185 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04.